ArticleDeveloping world bioethics2012
US IRBs confronting research in the developing world.
Article in Developing world bioethics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
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Who cites it
29 citing papers in PubMed.
- Making research ethics work for global health: towards a more agile and collaborative approach.BMJ global health · 2023Article
- "How about me giving blood for the COVID vaccine and not being able to get vaccinated?" A cognitive interview study on understanding of and agreement with broad consent for future use of data and samples in Colombia and Nicaragua.PLOS global public health · 2023Article
- Standards of evidence for institutional review board decision-making.Accountability in research · 2021Article
- Retrospective Chart Review of Voluntary Admissions to an Inpatient Psychiatric Hospital in New York City: A Demographic Breakdown.Community mental health journal · 2020Article
- Article
- Knowledge, Attitudes, and Practice Regarding Research Ethics Committees Among Health Care Faculty at Two Public Universities in Jordan.Journal of empirical research on human research ethics : JERHRE · 2019Article
- Practical challenges and Obligations for conducting Clinical Trial in Nepal: A call for improvement.Nepal journal of epidemiology · 2019Article
- Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.BMC medical ethics · 2019Article
- "The way the country has been carved up by researchers": ethics and power in north-south public health research.International journal for equity in health · 2016Article
- Barriers to Effective Deliberation in Clinical Research Oversight.HEC forum : an interdisciplinary journal on hospitals' ethical and legal issues · 2016Article
- Reviewing HIV-Related Research in Emerging Economies: The Role of Government Reviewing Agencies.Developing world bioethics · 2016Review
- Providing ethical guidance for collaborative research in developing countries.Research ethics · 2015Article
- A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.PloS one · 2015Article
- Post-approval monitoring and oversight of U.S.-initiated human subjects research in resource-constrained countries.Journal of bioethical inquiry · 2014Article
- How US institutional review boards decide when researchers need to translate studies.Journal of medical ethics · 2014Article
- Fostering IRB collaboration for review of international research.The American journal of bioethics : AJOB · 2014Review
- How IRBs view and make decisions about social risks.Journal of empirical research on human research ethics : JERHRE · 2013Article
- How IRBs view and make decisions about coercion and undue influence.Journal of medical ethics · 2013Article
- How IRBs view and make decisions about consent forms.Journal of empirical research on human research ethics : JERHRE · 2013Article
- Views of IRBs Concerning their Local Ecologies: Perceptions of Relationships, Systems, and Tensions between IRBs and their Institutions.AJOB primary research · 2013Article
Corrections and comments
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Authors and funding
1 author.
Funding
Abstract
unlabelledIncreasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.
methodsI conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).
resultsUS IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and 'negotiate' for maximum benefits for participants and fearing 'worst-case scenarios'.
conclusionsUS and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.